I.D. AND SEAKEM GTG AGAROSES
FDA 510(k) clearance K940037 · decided 1995-02-24
Clearance details
- K-number
- K940037
- Device name
- I.D. AND SEAKEM GTG AGAROSES
- Applicant
- Fmc Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-04
- Decision date
- 1995-02-24
- Days to decision
- 416 days
- Clearance type
- Traditional
- Product code
- JZR
- Device class
- 1
- Regulation number
- 866.4900
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TITAN GE/IEPLATE (K831603) | Helena Laboratories | 1983-07-07 |
Recalls involving this device
No recalls on record reference this clearance.